The following data is part of a premarket notification filed by Endovations with the FDA for Alligator Jaw Grasping Forcep (model 23/125).
Device ID | K874004 |
510k Number | K874004 |
Device Name: | ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125) |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Contact | Susan P Bjorkman |
Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-01 |
Decision Date | 1987-12-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10350770927647 | K874004 | 000 |
10350770927630 | K874004 | 000 |
10350770927623 | K874004 | 000 |
10350770927616 | K874004 | 000 |
10350770927609 | K874004 | 000 |
10350770927593 | K874004 | 000 |